Nanox files 510(k) for multisource tomo x-ray

By staff writers

June 17, 2021 -- X-ray developer Nanox said it has applied for 510(k) clearance with the U.S. Food and Drug Administration (FDA) for the first version of the company's multisource 3D digital tomosynthesis x-ray system.

The company positioned the filing as a major achievement in its quest to bring its multisource Nanox.ARC system to market. Nanox in April announced clearance of a version of Nanox.ARC that uses a single x-ray source.

The multisource version of Nanox.ARC is a more sophisticated version of the single-source system, with multiple x-ray sources arrayed around the patient to enable 3D tomosynthesis acquisitions. Nanox is positioning its systems as cost-effective products that could make medical imaging more accessible in developing parts of the world.

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